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IIT Bombay, Indian Drug
Manufacturers’
Association (IDMA) & Organisation of Pharmaceutical Producers of India
(OPPI)
Jointly present a One-day Workshop
On
UNMET NEEDS IN DRUG DELIVERY
TECHNOLOGIES
Organized as a part of N.R. Kamath Chair Professorship
Date: February 25th
​ ​, 2017
Key Note Speaker​: ​Prof. Samir Mitragotri (N.R. Kamath Chair Professor)
Convenor​ :
Advisory Committee
(​N.R. Kamath Chair Professorship)
Mr. Dipak Himatsingka
(Distinguished Alumnus of IIT Bombay)
Prof.​ Devang Khakhar (Director, IIT Bombay)
Co- Convenors​ :
Prof. Pramod P.Wangikar (Professor, IIT
Bombay)
Mr. Daara B.Patel (Secretary General,
IDMA)
Prof. Man Mohan Sharma
Mr. ​Dipak ​Himatsingka
Prof. ​Raghunath Anant Mashelkar
Mr. Vivek Padgaonkar (Director-Project &
Policy-OPPI)
Venue: Victor Menezes Convention Center
IIT Bombay
Introduction​:
The N.R. Kamath Chair for Institutional Excellence was set up by the alumni who graduated
between 1962 and 1973. The Chair is named after late Prof. N. R. Kamath who played a decisive role
as an academician and administrator during the formative phase of growth of not only the Chemical
Engineering Department of IIT Bombay but also of the Institute. Prof. Kamath was the first Deputy
Director of the Institute and is credited with being responsible for setting up the academic systems of
IIT Bombay. Prof. Samir Mitragotri is the first recipient of the NR Kamath Chair Professorship.
Background:
One of the challenges faced by the pharmaceutical and biotechnology
products is to deliver drugs at the right dose and at the right time. These
challenges exist for small as well large molecule drugs. The current
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methods of drug delivery are limited to specific challenges that scientists are attempting to address.
For example, many drugs’ potencies and therapeutic effects are limited or otherwise reduced because
of the partial degradation that occurs before they reach their desired target in the body. The benefits
of drug delivery systems manifest in many ways, for instance, once ingested, time-release
medications deliver treatment continuously, rather than providing relief of symptoms and protection
from adverse events solely when necessary. The surge of biologics in recent time has made delivery
challenges particularly important owing to the additional issues that they pose arising from their
large size. Drug delivery technologies have the potential to address several of these challenges
including formulation strategies, penetration enhancement methodologies and devices for controlled
drug administration. Over the last decade, the field of drug delivery has witnessed a major boom in
research and development, and these technologies are now in a position to transform pharmaceutical
and biotechnology products.
Target Audience:
● Pharma companies that are interested in newer formulations and drug delivery technologies.
● Senior management and R&D personnel from pharmaceutical organizations.
● Doctors interested in drug delivery technologies.
Objectives of the workshop:
● To identify the gaps and challenges in drug delivery technologies.
● To understand the recent technological advances in the field, including strategies for oral,
topical/transdermal and targeted drug delivery for applications in oncology, cardiovascular
diseases, infectious diseases and CNS disorders etc.
● To discuss challenges in the production of new therapeutics & the opportunities for
commercialization of technologies; path towards translation.
● Industry academia interaction and collaboration on potential commercializable technologies.
● To discuss the regulatory and IP aspects of drug delivery systems.
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Agenda
Time
Title
Speaker
9:00 - 10:00 a.m.
Registration and Tea/Coffee
10:00 - 11:30 a.m.
Keynote address: ​Challenges and Opportunities in
Drug Delivery Technologies for Pharmaceutical and
Biotechnology Products
Panel Discussion: Identifying technologies that can be
commercialized.
Industry Speaker 1
11:30 – 12:30 a.m.
12:30 - 12:50 p.m.
Prof. Samir Mitragotri
TBD
TBD
Lunch: Poster and networking session
12:50 - 2:00 p.m.
2:00 - 2:20 p.m.
High Cell Density Cultivation for Production of
Therapeutic proteins
2:20 - 2:40 p.m.
Industry Speaker 2
2:40 - 3:00 p.m.
Nanoparticles help deliver drugs across all medicinal
systems: studies in Allopathic, Ayurvedic and
Homeopathic Medicines
Prof. Jayesh Bellare
3:00 - 3:20 p.m.
Smart Material Platforms for Drug Delivery
Prof. Rinti Banerjee
Prof. Pramod Wangikar
TBD
Tea/Coffee break
3:20 – 3:50 p.m​.
Prof. Rohit Srivastava
3:50 - 4.10 p.m.
Wearable Microneedle assisted transdermal drug
delivery system
4:10 - 04:30 pm
Industry Speaker 3
TBD
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04:30 - 4:50 pm
04:50 - 6:00 pm
Towards microfluidic point-of-care diagnostic
technologies
Laboratory Visits
Prof. Debjani Paul
Dinner
7:00 pm Onwards
organs in the body in the right dose and at the right
time? At a fundamental level, this
challenge reflects the fact that the human
body has developed an elaborate
transportation system to dispose drugs.
This transportation system limits the drug dose that
ultimately reaches the target site, and some drugs
simply fail to reach their target.
Effective delivery of drugs is a major problem in
today’s healthcare. At a fundamental level, the
challenge of drug delivery reflects the fact that
body’s natural metabolic processes and transport
barriers limit drug distribution in the body. These
biological barriers, while serving an important
purpose of regulating body’s metabolic functions,
limit the drug dose that ultimately reaches the
target site. Accordingly, many drugs fail to reach
their full therapeutic potential. Our research aims
at developing a fundamental understanding of
body’s key biological barriers such as skin and
Title: Challenges and Opportunities in Drug
Delivery Technologies for Pharmaceutical and
Biotechnology Products
Prof. Samir Mitragotri ​(Chemical Engineering)
We wish our medicines to be quick, effective,
easy-to-take and have no side effects. Today’s
medicines, however, are far from this ideal picture
and have significant shortcomings. For example,
insulin, used for the treatment of diabetes, has to
be injected using needles, which have serious
limitations
of
pain and needle-phobia.
Chemotherapeutic drugs, used for the treatment of
cancer, have serious side effects of hair loss and
nausea. These limitations have raised a ‘delivery’
challenge, that is, how to deliver drugs to specific
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intestinal epithelium, and utilizing this
understanding to develop novel means to negotiate
these barriers to deliver drugs. I will present an
overview of our research as well as our strategies
to advance these technologies into the clinic
through a collaborative interaction with early-stage
and established biotech and pharmaceutical
companies.
modifications to improve soluble protein
production. Our strategy uses minimal medium
and involves growth under carbon limiting
conditions, step-down of temperature and oxygen
transfer rate at the time of induction, and sustained
supply of nitrogen. We believe that the strategy
will have wide-ranging implications for production
of bio-therapeutics.
Title: High Cell Density Cultivation for
Production of Therapeutic proteins
Prof. Pramod Wangikar​ (Chemical Engineering)
Title: Nanoparticles help deliver drugs across
all medicinal systems: studies in Allopathic,
Ayurvedic and Homeopathic Medicines
Prof. Jayesh Bellare​ (Chemical Engineering)
Commercial
exploitation
of
bio-therapeutics
necessitates a robust method for production that yields
high protein titer. Escherichia coli, a commonly used
host strain, typically provides relatively low protein titer
in a batch process. Some fed-batch protocols produce
high levels of protein in inclusion bodies, which require
extensive post-
Nanomedicines have proven their advantages
in many modern medicinal molecules, where
they often show significantly improved
performance. I will draw examples from my
groups’ research to show our ability to deliver
modern medicines for retinal cancer directly
through the eye, thereby overcoming natural
barriers that have prevented efficient delivery
to specific target tissues. I will show the
importance of modern tools like cryo-electron
microscopy in this field of work. Using
electron microscopy methods, together with
other modern analytical methods like atomic
spectroscopy, we show that traditional
medicines like Ayurvedic medicine, and
alternative medicines like Homeopathy, also
have nanoparticles in them, and these
nanoparticles
facilitate
drug
action.
Nanoparticles show improved biological
activity.
In Homeopathic medicines, a
controversy has existed regarding the high
processing and results in loss of yield. Other
expression systems involve extensive trials and are
not readily accessible to all researchers. We report
a fed-batch, high cell density cultivation protocol
for the production of soluble proteins in ​E. coli
BL21 (DE3) with over 25-fold improvement in
titer. The fed-batch strategy was based on the
reported high cell density protocols for ​E. coli with
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dilutions used (one part in 10 raised to 400
parts) during manufacture, which goes against
Avogadro’s number and the molecular basis of
matter. This has ruled out the possibility of the
presence of any starting material of the
medicine in the highly diluted finished
product. Because of this, the molecular basis
of the medicinal action of the drug was always
in doubt. Using electron microscopy, we show
for the first time that nanostructures like
nanocrystals of the starting materials are
present in the final product despite the
extremely high dilutions. These studies in the
materials science of various medicinal
systems, could pave the way for new
medicines and better health for all.
Title: Smart Material Platforms for Drug
Delivery
Prof.
Rinti
Banerjee
​(Biosciences
Bioengineering)
Title: "Wearable Microneedle assisted
transdermal drug delivery system"
Prof. Rohit Srivastava ​(Biosciences &
Bioengineering)
Microneedles are solid or hollow pointed
sub-millimetre devices that can pierce skin
and deliver a compound. In contrast to
adhesive skin patches, which rely on drug
absorption from the skin surace, microneedles
penetrate through the stratum corneum (the
outermost layer of the skin with a thickness of
up to 20 μm) and deliver the drug directly
underneath it. Thus, as a result, microneedles
increase skin permeability to several
hydrophilic and lipophilic compounds, and
therefore can potentially allow administration
of a much wider range of drugs compared with
adhesive patches. They also do not penetrate
deeper than the epidermal skin layer (with a
typical thickness of 120 μm) to contact nerves
and blood vessels and therefore, they are
painless and less associated with the risks of
device contamination. This research talks
about designing of novel and alternative
approach for addressing emesis by developing
a wearable microneedle-based transdermal
drug delivery patch which can imitate the
same mechanism of pharmacological actions
exhibited by current mode of administration
and doses of drugs used for treatment of
emesis without any notified side-effects and
better patient compliance.
&
The talk will deal with nanoparticles, in situ
gels and transdermal patches for site specific
and stimuli responsive drug delivery. The
technologies allow enhanced drug penetration,
delivery of hydrophobic drugs, reduction of
toxic effects and stabilization of labile drugs
through non-invasive routes. These include
aerosols, core-shell oral nanoparticles, in situ
nanoparticle in gels for mucosal delivery,
transdermal patches, intra-articular and
intravesical
platforms
for
sustained
site-specific drug delivery
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Also, for the first time with our wearable
therapeutic gadget,
we
hope
to
transform
how
medicine is delivered and how people achieve
health-goals
through
convergence
of drug-delivery,
medical-microsystem
technology
with
connected
and
personalized behavioural support.
Title: Towards microfluidic point-of-care
diagnostic technologies
Prof.
Debjani
Paul
(Biosciences &
Bioengineering)
There is a strong need for affordable and
accurate disease detection in developing
countries like India in order to provide good
quality healthcare to the population.
Microfluidics can help in miniaturizing
diagnostic platforms so that these can be used
at the point-of-care. We have focused on
developing diagnostic technologies that are
inexpensive, can be operated without
continuous electrical power and can be stored
without refrigeration. In my talk, I will
describe two such
platforms: (a) a paperfluidic platform for
DNA-based detection of tuberculosis, and (b)
a mobile microscopy and microfluidic
platform for automated shape-based diagnosis
of sickle cell disease.
Samir Mitragotri
Dr. Samir Mitragotri is a
Professor
of
Chemical
Engineering at the University of
California,
Santa
Barbara
(UCSB). He is also the founding
Director of the Center for
Bioengineering at UCSB. Prof.
Mitragotri is the first recipient of the N. R. Kamath
Chair Professorship for Institutional Excellence at
IIT Bombay. Professor Mitragotri received Ph.D.
from MIT in 1996 and B.S. from the Institute of
Chemical Technology (ICT), Mumbai in 1992,
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both in Chemical Engineering. Professor
Mitragotri’s research is focused on drug delivery.
He has developed innovative technologies for
needle-free drug delivery via skin patches and oral
pills, which are easy-to-use and patient-friendly. In
addition, Prof. Mitragotri has also developed new
methods of targeted drug delivery for the treatment
of cancer and vascular diseases. Professor
Mitragotri has published over 200 papers in
leading journals. He is 2015 Thomson Reuter
Highly Cited Researcher. Professor Mitragotri has
received numerous awards for his work including
his election to the National Academy of
Engineering (NAE) in 2015. He is also an elected
fellow of the National Academy of Inventors
(NAI), American Association of Advancement of
Science (AAAS), Biomedical Engineering Society
(BMES) and many others. He was among the first
to be recognized with the Technology Review
Young Inventor award (TR35) for technological
innovation and is a recipient of the Distinguished
Alumnus award from ICT and many others.
Professor Mitragotri is Editor-in-Chief of
Bioengineering & Translational Medicine and
Associate Editor of Journal of Controlled Release.
He has placed a strong emphasis on converting his
discoveries into clinically usable technologies for
the benefit of patients. He is an inventor on over
100 issued and pending patents that have been
licensed by numerous companies that have
developed (and are developing) pharmaceutical
and medical products.
Pramod Wangikar (ChE)
Prof. Pramod P. Wangikar is
a
Professor
in
the
Department of Chemical
Engineering
and
the
Professor-in-charge (PIC) of
Wadhwani Research Center
for Bioengineering (WRCB), an
interdepartmental center of IIT Bombay. Prof.
Wangikar obtained his Bachelor of Chemical
Engineering from Institute of Chemical
Technology, Mumbai and Ph.D. from University
of Iowa, USA. He has interests in bioprocess
development,
biocatalysis
and
metabolic
engineering. Prof. Wangikar has published over 70
papers in international journals. Currently, he also
heads the “DBT-Pan IIT Center for Bioenergy”, a
virtual center that involves 21 investigators spread
across five IITs. He works closely with industry
and takes up projects that are relevant to the local
industry. He has also served as a consultant to
various industries such as Orchid Chemicals and
Pharmaceuticals, Lupin Ltd., Persistent Systems
Ltd., Reliance Industries Ltd. and Hi Tech
BioSciences Ltd.
Jayesh Bellare (ChE)
Prof. Bellare is “Institute
Chair Professor” of Chemical
Engineering at the Indian
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Institute of Technology, Bombay. He is an elected
Fellow of the National Academy of Science, India,
the Indian National Academy of Engineering, The
Maharashtra Academy of Sciences, and the
Electron Microscopy Society of India. He is also a
WRCB core committee member. He obtained a
B.Tech in Chemical Engineering from IIT
Bombay, a Ph.D. in Chemical Engineering and
Materials Science from University of Minnesota,
USA, and Post-Doctoral work at M.I.T., USA. He
was the first Head of IITB’s Department of
Biosciences and Bioengineering. He is also with
IITB’s Nanotechnology Center. He has more than
twenty years of worldwide experience in
nanotechnology,
cryo-electron
microscopy,
hollow-fiber membranes, Nano medicines and
biomedical devices. He has numerous publications,
patents and awards, including the Distinguished
Visiting Professorship at the University of
Minnesota,
USA
and
the
National
Academy-Reliance Platinum Jubilee Award for
application-oriented research.
based nano-particles for drug delivery. She has
received several awards in recognition of her work
and is a member of the editorial board of several
international journals. Dr. Banerjee has over 100
international journal publications and has several
patented technologies to her credit.
Rohit Srivastava (BSBE)
Prof. Rohit Srivastava is a
professor in the Department of
Biosciences and Bioengineering
at the Indian Institute of
Technology, Bombay. Dr.
Srivastava
completed
his
Bachelor of Engineering in Electronics
Engineering from VNIT Nagpur and a Masters and
PhD in Biomedical Engineering from Louisiana
Tech University, Ruston, LA, USA. Dr.
Srivastava’s lab in collaboration with Biosense
Technologies Pvt. Ltd. have developed and
commercialized “UChek” a portable urine analysis
system based on the mobile platform and have also
made a low cost reader for quantitatively analyzing
urine dip sticks for which he received the DBT
Biotech Process and Product Commercialization
Award 2015 and the OPPI Young Investigator
Award 2014. He has been awarded the prestigious
Vasvik Award 2013 for Biological Sciences and
Technology for Suchek, which is an indigenous,
accurate, low-cost glucometer supported by the
Indian Council of Medical Research. Dr.
Srivastava is also the recipient of the prestigious
Tata Innovation Fellowship Award from DBT for
his translational ​work on diagnosing orthopedic
implant
Rinti Banerjee (BSBE)
​Prof. Banerjee a medical doctor
with an MBBS from BJ Medical
College, Pune, and a PhD in
Biomedical Engineering from IIT
Bombay. Currently, she is the
Madhuri Sinha Chair Professor
(BSBE) and HOD of the Department of BSBE.
She is also a WRCB Core Committee member and
is associated with other centres as well. Prof.
Banerjee has been recognized for her contributions
in the area of nano-medicine, specifically lipid
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Bangalore. She was a postdoctoral fellow in the
Physical Chemistry Unit (UMR 168) of Curie
Institute, Paris, from 2005-2007, where she
developed new techniques to fabricate microfluidic
chips using plastic substrates. As a Research
Associate in the Electrical Engineering division,
University of Cambridge (2007-2009), Prof. Paul
explored electrical biosensing techniques to detect
interactions between proteins. She moved to the
Biological and Soft Systems group in the
Cavendish laboratory, University of Cambridge in
2009 to study the biophysical mechanisms of
phagocytosis in macrophages using microfluidics
and live cell imaging techniques. She is currently
an Assistant Professor in the Department of
Biosciences and Bioengineering, IIT Bombay. Her
research group in IIT Bombay uses microfluidic
technology to build point-of-care diagnostic
platforms. Some of the ongoing projects in her lab
are: (1) developing a paperfluidic chip for
tuberculosis screening in low-resource settings, (2)
detection of sickle cells in blood using a
microfluidic chip integrated with a mobile
microscope, and (3) identifying rare cells in blood
using deformability cytometry. The projects are
funded by DBT (Govt. of India), Bill and Melinda
Gates Foundation, Tata Trust and WRCB.
related infections. Dr. Srivastava’s lab won an
award in the prestigious Healthcare Innovation
World Cup organized by HIT Lab on solutions to
management of diabetes. The Welcome Trust UK
has further funded this project for making an
affordable point of care reader for critical care
analytes. Dr. Srivastava’s lab is also the winner of
prestigious ‘Samsung Innovation Award 2012’
organized by IIT Delhi (August 2012) for
innovation ‘Drishti’ which was transferred to Titan
Eye for further development. Dr. Srivastava is a
core committee member of WRCB as well as task
force member on various panels in DBT, BIRAC,
ICMR and DST. His lab has filed several Indian
and International patent applications and has
published in over 75 peer-reviewed journals.
Debjani Paul (BSBE)
Prof. Debjani Paul obtained a
Ph.D. in Physics (2005) from
Indian Institute of Science,
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Contact Details:
Convenor: ​Mr.Dipak Himatsingka
Email id:
(Office) Phone:
Co -Convenors:
Prof. Pramod P.Wangikar
Email Id: ​[email protected]
Office: 022-27567232
Mr. Daara B.Patel
Email Id: ​[email protected]
Office: 022 - 2494 4624
Mr. Vivek Padgaonkar (OPPI)
Email Id: ​[email protected]
Office: 022- 2491 8123
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